There is an increasing use of long-term contraceptives, of which one type is a subdermal implant in the form of a rod that releases contraceptive hormone, until it needs to be removed or replaced with a new rod. For example, Nexplanon [Schering-Plough Limited/Merck, Sharp & Dohme Limited (MSD) US] is a subdermal implant indicated for use as a long-term contraceptive for women. It entered the European market in 2010, replacing Implanon (available in Europe and SE Asia since 1998, and approved in the US in 2006), the most widely used implantation system in the world, marketed in 32 or more countries throughout the world. The implant of both Implanon and Nexplanon is a 4 cm long, 2 mm diameter non-biodegradable ethylene vinyl acetate (EVA) copolymer core, containing 68 mg of the synthetic progestin etonogestrel, surrounded by a rate-controlling EVA copolymer membrane. The implant must be replaced or removed 3 years after insertion.
Other contraceptive implants are Jadelle, 43 mm long, 2.5 mm diameter (2 rods), lasts 5 yrs, and Sino-Implant II, 44 mm long, 2.4 mm diameter (2 rods), lasts 4 yrs.
Increased focus on the benefits of long-acting, reversible contraception has spurred an increase in CI insertions in recent years, both in industrialised and developing countries. On a global scale, multiple campaigns have been launched to meet UN Millennium Goals 4 and 5, i.e. reduction of maternal and child mortality, and a steep increase in CI procurement is expected for the foreseeable future. A large and increasing number of women will therefore need to have their CIs removed.
Since CIs were introduced to the commercial market in the early 1980s, implant manufacturers have focused intense efforts on making insertion of CIs easier. For instance, a unique, preloaded disposable applicator developed for Nexplanon ensures “fail proof” and efficient subdermal insertion of the implant. CI removals, on the other hand, have largely been left untouched and at the mercy of the various service providers. The CI removal procedure recommendations have remained essentially unchanged for 40 years, relying on general surgical skills from the service provider.
While contraceptive implant (CI) insertion is easily managed through the use of specialised introducer trocars, CI removal is a complex task that requires specialist training. There exists no standardised method for CI removal, and no dedicated removal devices are available on the global market. Currently, CIs are removed using scalpels and forceps and rely on the general surgical skills of the service provider.
The currently accepted procedure generally involves a minimum of three essential steps. Firstly, the position of the CI beneath the skin is identified through palpation; secondly an incision of appropriate size must be made at a suitable position relative to the CI; the CI must then be relocated and extracted, typically by using forceps brought through the incision in the skin.
The complexity of the procedure means that it is highly variable in duration and often cumbersome, both for the patient and for the clinician. The complex current CI removal procedure is a major impediment to a desired increase of CI use.
Introducing a simple, safe and effective CI removal procedure could improve patient care, be cost-effective for CI service providers and increase access to complete CI care. All available research shows that the procedure length of the current CI removal procedure is highly variable and heavily reliant on individual operator skills.
More recently, in WO 2013/156628, devices have been described which allow for an implant to be held in a fixed, known position beneath the skin, thus facilitating a standardised approach to the removal procedure by offering a precise point of entry of a scalpel in relation to the implant lying beneath the skin. Such devices aid in reducing the complexity of the procedure by providing a simple method to achieve the first step of the procedure leaving the operator free to complete the remaining steps.
Although such devices make progress in reducing the complexity of the procedure, the remaining stages of making an incision in the skin and extracting the implant are those that require the most operator skill. The time required and the outcome quality of the finished procedure are therefore still highly variable.
Accordingly there exists a need for providing a means to remove a contraceptive implant from beneath the skin which reduces the complexity of the process such that it does not require a high level of operator skill, which also further reduces the time required to remove the implant and reduces the variation in the outcome of the procedure.